NCT02950428已完成不适用
ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE Neo™ TA Transapical Delivery System in Patients With Severe Aortic Stenosis
Symetis SA14 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年11月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- Primary Safety: freedom from all-cause mortality
研究概览
简要总结
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.
详细描述
This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention.
The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery Secondary objective is to evaluate adverse events and study device performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years old
- •Severe aortic stenosis defined as:
- •Mean aortic gradient > 40 mmHg or
- •Peak jet velocity > 4.0 m/s or
- •Aortic valve area of < 0.8 cm2
- •High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum
- •NYHA Functional Class > II
- •Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions:
- •porcelain aorta or
- •severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or
- •vessels too small for retrograde approach or
- •other anatomical conditions making transapical approach more suitable
- •Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE
- •Patient willing to participate in the study and provides signed informed consent
排除标准
- •Congenital unicuspid or bicuspid aortic valve or non-calcified
- •Extreme eccentricity of calcification
- •Severe mitral regurgitation (> Grade 3)
- •Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- •LV apex is not accessible via transapical access due to severe chest deformity
- •Previous surgery of the LV using a patch, such as the Dor procedure
- •Presence of apical LV thrombus
- •Calcified pericardium
- •Septal hypertrophy unacceptable for transapical procedure
- •Transesophageal echocardiogram (TEE) is contraindicated
- •ECHO evidence of intracardiac mass, thrombus, or vegetation
- •LVEF < 20% by ECHO
- •Need for emergency intervention for any reason within 30 Days of scheduled procedure
- •Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
- •Untreated clinically significant coronary artery disease requiring revascularization within 30 days before or after the study procedure
- •Acute myocardial infarction within 1 month prior to implant procedure
- •Previous TIA or stroke within 6 months prior to implant procedure
- •Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure
- •Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
- •History of bleeding diathesis, coagulopathy, refusal of blood transfusions or severe anemia (Hb<8 g/dL)
- •Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
- •Primary hypertrophic obstructive cardiomyopathy (HOCM)
- •Active infection or endocarditis
- •Hepatic failure (> Child B)
- •Chronic renal dysfunction with serum creatinine > 3.0 mg/dL or renal dialysis
- •Neurological disease severely affecting ambulation, daily functioning, or dementia
- •Life expectancy < 12 months due to non-cardiac co-morbid conditions
- •Intolerance to aspirin, clopidogrel, contrast media, or porcine tissue and allergy to nickel
- •Pregnant or breast-feeding women
- •For other severe illnesses of the patient (e.g. active carcinoma), the investigator shall decide on an individual basis whether the patient is not to be included in the study
- •Currently participating in an investigational drug or another device study
结局指标
主要结局
Primary Safety: freedom from all-cause mortality
时间窗: 6 months post procedure
freedom from all-cause mortality
Primary Device Performance:Procedure success in absence of MACCE
时间窗: 30 days post procedure
Procedure success in absence of MACCE
次要结局
- NYHA Functional Classification improvement(30 Days, 6 Month and at 12 Months)
- Incidence of all cause mortality at 30 Days and 12 Months(30 days and 12 months)
- Rate of device success(7 days/ Discharge, 30 Days, 6 Months and at 12 Months)
- Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures(7 Days or Discharge, 30 Days, 6 Months, 12 Months)
- Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines(30 Days and month 12)
- Freedom from MACCE at 30 Days, 6 Months and 12 Months(30 Days, 6 Months and 12 Months)
- Number of patients who have a Procedural success defined by a combination of criteria(procedure)
研究者
研究点 (14)
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